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AstraZeneca's roxadustat boosts haemoglobin levels in two Phase 3 trials

Published on 08/11/19 at 11:14am

AstraZeneca’s hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) roxadustat has made a strong showing in the treatment of deficient haemoglobin (Hb) levels in non-dialysis-dependent (NDD) and dialysis-dependent (DD) patients with anaemia as a result of chronic kidney disease after meeting its primary endpoint in two separate clinical trials.

In the first, the OLYMPUS trial, AZ’s drug was shown to increase hB levels from baseline by a mean 1.75g/dL averaged over weeks 28 to 52, compared to 0.40g/dL with placebo.

Furthermore, in patients with high-sensitivity C-reactive protein (hsCRP) levels of greater than 5mg/L, the therapy also decreased hB levels by an average of 1.73g/dL versus 0.62g/dL with placebo, meeting the study’s secondary endpoint.

In the second, the ROCKIES trial, roxadustat demonstrated an average hB improvement from baseline of 0.77g/dL between week 28 and week 52. This was compared to an average 0.68g/dL increase with epoetin alfa.

In patients with hsCRP levels  higher than 5mg/L, the drug also improved hB levels by a  mean 0.80g/dL, compared to 0.59g/dL with epoetin alfa.

“These data demonstrated that roxadustat effectively increased haemoglobin levels for patients with anaemia from chronic kidney disease, including those who show signs of inflammation,” commented Dr Steven Fishbane, Zucker School of Medicine at Hofstra/Northwell in New York and primary investigator on the OLYMPUS and ROCKIES trials. “Patients who experience chronic inflammation are often more difficult to treat than the overall chronic kidney disease patient population, emphasising the need for new treatment options.”

Mene Pangalos, Executive Vice President at AZ’s BioPharmaceuticals R&D, remarked: “Anaemia is a common, serious condition among patients with chronic kidney disease. It occurs when the body has fewer healthy red blood cells than normal and low levels of haemoglobin, which may leave patients fatigued and short of breath. Results from OLYMPUS and ROCKIES reinforce the potential role that roxadustat could play in increasing haemoglobin levels and managing anaemia, which is often underdiagnosed and undertreated.”

Matt Fellows

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